MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. D-DIMER 25 TEST KIT; CARDIAC MARKER TEST

Model Number 98100

Device Problem Low Test Results (2458)

Patient Problems Pain (1994); Thrombus (2101)

Event Date 02/12/2015

Event Type  Injury  

Event Description

Caller alleged discrepant low d-dimer results.Results as follows: customer called to obtain the normal/reference range for the d-dimer device.Patient presented with leg pain.The triage d-dimer result was 211ng/ml.Ultra sound revealed a venous leg clot.The patient is now an inpatient at a nearby hospital.No further information was provided.

Manufacturer Narrative

No discrepant low results were observed with any devices tested with cm calibrator h.Data results from all devices tested were within manufacturing final release specifications.No device issues or error codes were observed during testing.No sample was returned to product support.Unable to rule out sample specific interference as a potential cause for discrepant results.A review of manufacturing batch records indicated that no discrepant low results were observed during manufacturing final release testing.No product deficiency was established.Corrective action is not required at this time.

• Brand Name: D-DIMER 25 TEST KIT
• Type of Device: CARDIAC MARKER TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4596520
• MDR Text Key: 18651761
• Report Number: 2027969-2015-00183
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 98100
• Device Lot Number: W59317B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 33 YR